JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
ACICLOVIR
30mg/g (3%) eye ointment, 4.5g
DRUG TYPE OR
USE
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
Herpes simplex
keratitis
Temporary Restricted Benefit
listing of as an alternative to
currently listed aciclovir
(Zovirax).
The PBAC recommend the temporary Restricted Benefit listing of aciclovir
(AciVision) on the PBS as an alternative to currently listed but unavailable,
aciclovir (Zovirax), to ensure access to a treatment for Herpes simplex
keratitis.
Chronic obstructive
pulmonary disease
Authority Required
(STREAMLINED) listing for
the treatment of patients with
chronic obstructive
pulmonary disease.
The PBAC recommended the listing of aclidinium/eformoterol fixed dose
combination (FDC) as an Authority required (STREAMLINED) benefit for the
treatment of chronic obstructive pulmonary disease for patients already
stabilised on concomitant long acting muscarinic receptor antagonist (LAMA)
and long-acting selective β2 agonist (LABA) therapy.
ACIVISION®
Medsurge Healthcare Pty Ltd
New listing
(Minor Submission)
ACLIDINIUM BROMIDE with
EFORMOTEROL FUMARATE
DIHYDRATE
aclidinium 340 microgram/actuation
+ eformoterol 12
microgram/actuation inhalation:
powder for, 60 actuations
BRIMICA® GENUAIR®
A.Menarini Australia Pty Ltd
The PBAC recommended the listing on a cost-minimisation basis to the
existing LAMA/LABA fixed dose combinations, umeclidinium/vilanterol and
glycopyrronium/indacaterol. The equi-effective doses are considered to be
aclidinium 340 microgram with eformoterol 12 microgram (twice daily),
umeclidinium 62.5 microgram with vilanterol 25 microgram (daily), and
glycopyrronium 50 microgram with indacaterol 110 microgram (daily).
New listing
(Major Submission)
1
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
ANAKINRA
anakinra 100 mg/0.67 mL injection,
28 x 0.67 mL syringes
DRUG TYPE OR
USE
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
Cryopyrin-associated
periodic syndromes
Correspondence from the
Australasian Society of
Clinical Immunology and
Allergy requested that
immunologists be granted
prescribing rights for anakinra
for the treatment of cryopyrinassociated periodic
syndromes.
The PBAC recommended that the treatment criteria for this indication should
be modified to include prescribing by clinical immunologists.
Non-Hodgkin's
lymphoma
Re-submission for Section
100 (Efficient Funding of
Chemotherapy
arrangements) listing for the
first line treatment of indolent
non-Hodgkin's lymphoma
(iNHL) and mantle cell
lymphoma (MCL).
The PBAC recommended the listing of bendamustine for the treatment of iNHL
and MCL. The PBAC considered that bendamustine presented a less toxic
alternative to existing treatments for some patients with iNHL and MCL and
accepted that it improved progression free survival. The PBAC also
considered that listing of bendamustine on the PBS may potentially result in
cost savings to the Commonwealth.
KINERET®
A. Menarini Australia Pty Ltd
Change to listing
PBAC OUTCOME
(Correspondence)
BENDAMUSTINE
powder for injection 100 mg vial, 1
powder for injection 25 mg vial, 1
Ribomustin®
Jansen-Cilag Pty Ltd
New listing
(Minor Submission)
2
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
BOSENTAN; EPOPROSTENOL;
MACITENTAN
bosentan 62.5 mg tablet, 60;
bosentan 125 mg tablet, 60;
epoprostenol 500 microgram
injection vial, 1;
epoprostenol 1.5 mg injection vial,
1;
macitentan 10 mg tablet, 30
DRUG TYPE OR
USE
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
Pulmonary Arterial
Hypertension (PAH)
Removal of the following
requirements from the
'Continuing treatment'
restriction:
(i) patient must have been
assessed as having achieved
a response to their most
recent course of treatment;
and
(ii) clinicians must provide
evidence that a patient has
been assessed as having
achieved response when
wanting to prescribe
continued treatment.
The PBAC considered that progression of disease in patients on PAH agents
does not necessarily indicate that the therapy is no longer effective and that
the biggest response will most likely be achieved in response to the initial
treatment. The PBAC therefore agreed that it would be reasonable to have a
first continuing treatment restriction where evidence of a response to the PAH
agent must be demonstrated; and then a subsequent continuing treatment
restriction, which would not require further evidence of a response, i.e.
removal of the requirement for a patient to have been assessed as having
achieved a response to their most recent course of treatment, and thereby, the
removal of the requirement for clinicians to provide results from right heart
catheterisation omposite assessment, echocardiography composite
assessment and 6 minute walk test.
Elevated intra-ocular
pressure
Restricted Benefit listing for
the treatment of elevated
ocular pressure in adult
patients with open-angle
glaucoma or ocular
hypertension.
The PBAC recommended the Restricted Benefit listing of brinzolamide +
brimonidine FDC for the treatment of elevated intra-ocular pressure on a
cost-minimisation basis against a mixed comparator of dorzolamide + timolol
FDC and the individual components of brinzolamide and brimonidine.
TRACLEER®; VELETR®;
OPSUMIT®
Actelion Pharmaceuticals Australia
Pty Ltd
Change to listing
(Minor Submission)
BRINZOLOMIDE / BRIMONIDINE
TARTRATE suspension containing
brinzolamide 10 mg/mL +
brimonidine 2 mg/mL, 5 mL
Simbrinza®
Alcon Laboratories Australia Pty
Ltd
New listing
(Major Submission)
3
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
DAPAGLIFLOZIN and
METFORMIN XR
dapagliflozin 10 mg + metformin
hydrochloride 500 mg tablet:
modified release, 28
dapagliflozin 10 mg + metformin
hydrochloride 1000 mg tablet:
modified release, 28
dapagliflozin 5 mg + metformin
hydrochloride 1000 mg tablet:
modified release, 56
DRUG TYPE OR
USE
Type 2 diabetes
mellitus
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
Authority Required
(STREAMLINED) listing for
the treatment of type 2
diabetes as:
1) Triple oral therapy with
metformin and a sulfonylurea;
and
2) Add-on to insulin therapy.
The PBAC recommended that the recommended listing of
dapagliflozin+metformin XR for the treatment of type 2 diabetes mellitus be
extended to include use in the add on to insulin and triple oral therapy settings,
consistent with the current listings for dapagliflozin.
XIGDUO® XR
AstraZeneca Pty Ltd
Change to recommended listing
(Minor Submission)
4
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
DEFERASIROX
125 mg dispersible tablet, 28
250 mg dispersible tablet, 28
500 mg dispersible tablet, 28
DRUG TYPE OR
USE
Chronic iron overload
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
Section 100 (Highly
Specialised Drugs Program)
Authority Required listing for
the treatment of chronic iron
overload.
PBAC OUTCOME
The PBAC recommended revising the PBS restriction for deferasirox to an
Authority required Section 100 listing for patients with:
- transfusion dependent non-malignant disorders of erythropoiesis;
- non-transfusion dependent thalassemias; and
- transfusion-dependent malignant disorders with a median life expectancy
greater than five years.
EXJADE®
Novartis Pharmaceuticals Australia
Pty Limited
Change to recommended listing
(Major Submission)
The PBAC rejected the request to retain the current PBS restriction for
deferasirox for patients with “chronic iron overload in patients with disorders of
erythropoiesis” as this very broad restriction enabled major use outside
populations where cost-effectiveness has been demonstrated, in particular
myelodysplastic syndrome. The PBAC did not accept that a survival benefit
due to deferasirox therapy had been proved in myelodysplastic syndrome or
other malignant disorders and therefore the cost-effectiveness of deferasirox in
myelodysplastic syndrome generally was not adequately demonstrated.
However, the PBAC recognised that iron overload is a cause of major
morbidity and mortality in patients with longer survival, such as those with nontransfusion dependent thalassemias, and transfusion-dependent malignant
disorders with a median life expectancy greater than five years. Under the
restriction recommended by PBAC in November 2014, these patients could be
significantly disadvantaged. Thus, the PBAC considered, subject to price
negotiation, a revision to the restriction would be acceptable to allow use in
these patient groups, noting the uncertainty of cost-effectiveness even in these
subgroups.
5
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
EXENATIDE
2 mg, powder for injection, vial
BYDUREON®
AstraZeneca Pty Ltd
Change to recommended listing
(Major Submission)
DRUG TYPE OR
USE
Type 2 diabetes
mellitus
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
Re-submission for Authority
Required (STREAMLINED)
listing for the treatment of
type 2 diabetes mellitus as:
1) Dual combination therapy
with metformin or a
sulfonylurea; and
2) Triple combination therapy
with metformin and a
sulfonylurea; in a patient who
meets certain criteria.
The PBAC recalled that, in November 2013, it had recommended exenatide
2 mg once weekly as an Authority Required (STREAMLINED) benefit for dual
combination therapy with metformin or a sulfonylurea and triple combination
therapy with metformin and a sulfonylurea in patients with type 2 diabetes
mellitus, on a cost-minimisation basis with exenatide 10 mcg twice daily (with a
cost offset for reduced needle use).
The PBAC considered that the simplified treatment regimen of reducing dosing
frequency by 13 injections per week may translate into fulfilling an unmet need
for high clinical need populations; specifically Indigenous, aged and mental
health patients.
The PBAC re-endorsed its November 2013 recommendation (of cost
minimisation with a partial cost offset for reduced needle use) and
recommended a further small price advantage for exenatide 2 mg once weekly
on the basis of potential health benefits from likely improved adherence by a
small number of high clinical need populations.
6
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
FENTANYL CITRATE
(SUBLINGUAL)
100 microgram tablet: sublingual,
10 & 30,
200 microgram tablet: sublingual,
10 & 30,
300 microgram tablet: sublingual,
10 & 30,
400 microgram tablet: sublingual,
10 & 30,
600 microgram tablet: sublingual,
10 & 30,
800 microgram tablet: sublingual,
10 & 30,
DRUG TYPE OR
USE
Breakthrough pain
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
Re-submission for Authority
Required (Palliative Care
Schedule) listing for the
treatment of breakthrough
cancer pain.
The PBAC recommended listing fentanyl citrate sublingual tablets as an
Authority Required benefit on the Palliative Care Schedule for the treatment of
breakthrough pain in patients undergoing palliative care for cancer.
Restricted Benefit listing of an
alternative medicinal food for
patients with tyrosinaemia.
The PBAC recommended the restricted benefit listing of glycomacropeptide
and essential amino acids with vitamins and minerals, Tylactin® RTD 15 for the
treatment of tyrosinaemia on a cost-minimisation basis against TYR
Cooler® 20 and TYR Cooler® 15 on an equivalent price per gram of protein
basis.
The recommendation was made on a cost-minimisation basis with
immediate-release opioids and fentanyl lozenge (Actiq). Equi-effective doses
were not estimated, but assumptions were made for each pain episode to be
treated with one sublingual tablet or one lozenge. The PBAC considered that
the resubmission’s request of flat pricing across dose strengths addressed the
issue of variability during titration of short acting fentanyl for breakthrough
pain.
ABSTRAL®
A.Menarini Australia Pty Ltd
New listing
(Major Submission)
GLYCOMACROPEPTIDE and
ESSENTIAL AMINO ACIDS with
VITAMINS and MINERALS
15 g protein oral liquid, 30 x 250
mL tetra pack
Medicinal food
TYLACTIN® RTD
Cortex Health Pty Ltd
New listing
(Minor Submission)
7
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
INFLIXIMAB
100 mg injection vial, 1
100 mg injection vial, 3
100 mg injection vial, 4
INFLECTRA®
Hospira Pty Ltd
New listing
(Minor Submission)
DRUG TYPE OR
USE
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
Ankylosing
spondylitis,
Crohn's disease,
Psoriatic arthritis,
Rheumatoid Arthritis,
Plaque psoriasis,
Ulcerative colitis
Section 100 (Highly
Specialised Drugs Program)
Authority Required listing of
Inflectra (infliximab), a similar
biological medicinal product,
with the same indications and
restrictions as the currently
PBS listed brand of infliximab
(Remicade®).
The PBAC recommended the listing of infliximab (Inflectra) as a biosimilar of
infliximab (Remicade), on a cost-minimisation basis to infliximab (Remicade),
where the equi-effective doses are 100 mg infliximab (Inflectra) and 100 mg
infliximab (Remicade). The PBAC recommended that the same indications that
apply to infliximab (Remicade) should apply to infliximab (Inflectra).
In relation to the “a” flagging of the Remicade and Inflectra brands of
infliximab, the PBAC considered a range of factors including:
 There is evidence from three randomised clinical trials in treatment-naïve
patients initiating on either Inflectra or Remicade that support a finding that
Inflectra has equivalent effectiveness and equivalent safety compared to
Remicade.
 The key randomised clinical studies in rheumatoid arthritis and ankylosing
spondylitis did not indicate differences in efficacy or safety of Inflectra
compared with Remicade. The supportive evidence from a series of noncomparative studies in patients with Crohn’s disease or ulcerative colitis
demonstrates treatment with Inflectra is also effective and safe in these
conditions.
 The clinical data provided in the submission did not suggest that there were
any identified populations where the risks of using the biosimilar product in
place of the reference biologic are disproportionately high.
 In the two trials with extension studies (Study 1.1 and Study 3.1), switching
from Remicade to Inflectra occurred, and the clinical evidence suggested
no difference in efficacy, safety or immunogenicity between the biosimilar
and reference biologic in these studies.
 The ACPM has declared Inflectra a biosimilar for Remicade. The ACPM
was satisfied of the similar safety and efficacy of Inflectra and Remicade in
rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis,
ulcerative colitis and Crohn’s disease.
The PBAC advised the Minister that it considered the Remicade and Inflectra
brands of infliximab could be marked as equivalent in the Schedule of
Pharmaceutical Benefits (“a” flagged), for the purposes of substitution by the
pharmacist at the point of dispensing.
The PBAC noted that it had held a consumer hearing on biosimilars, and that
the issues discussed at the hearing in relation to biosimilar substitution had
been considered by the PBAC when making its recommendation.
8
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
DRUG TYPE OR
USE
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
The PBAC noted that there appeared a public misunderstanding about how
substitution occurs, and noted that the substitution process allows for patient
and prescriber choice and is not automatic. For any individual prescription, a
prescriber may choose to not permit brand substitution. If on the other hand,
substitution has been permitted by the prescriber, the patient may choose
which brand they wish to receive from the pharmacist. The PBAC noted that
in relation to concerns about traceability, that Medicare routinely collects
information on the brand of drug that is dispensed for a patient. In relation to
concerns about multiple switches of brands, the PBAC considered that this is
unlikely to occur in practice because infliximab is administered via an infusion
with most patients receiving all courses of treatment at a single centre,
reducing the likelihood of switches between brands.
The PBAC recommended that the Department develop an implementation
strategy for infliximab for the PBAC’s review before an “a” flag can be included
against the Inflectra and Remicade brands on the Schedule. This
implementation strategy should include an education campaign designed to
support and promote the use of biosimilars, improving awareness and
confidence by both health professionals and consumers to choose these
products.
The PBAC reiterated its position that it would consider the marking of
equivalent (i.e. “a” flagging) in the Schedule of biosimilar medicines with their
reference medicine on a case by case basis, taking into account the evidence
presented in each submission to list a biosimilar medicine.
9
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
INSULIN GLARGINE
300 unit/mL, 1 x 1.5 mL cartridge
300 unit/mL, 3 x 1.5 mL cartridge
300 unit/mL, 5 x 1.5 mL cartridge
TOUJEO®
DRUG TYPE OR
USE
Diabetes
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
Unrestricted benefit listing.
PBAC OUTCOME
The PBAC recommended insulin glargine U300 as an unrestricted benefit on
the basis of cost-minimisation to insulin glargine U100 for both type 1 and
type 2 diabetes mellitus. The PBAC rejected the claimed benefit in
hypoglycaemic events and the modelled cost effectiveness in type 2 diabetes
mellitus. The PBAC noted the supportive comments from consumers but
considered there was low clinical need for this additional formulation of insulin
glargine.
Sanofi-aventis
New listing
(Major Submission)
Type 1 diabetes mellitus:
On the basis of one head-to-head trial (EDITION IV) presented in the
submission, U300 appears to have the same effect on glycosylated
haemoglobin and frequency of adverse events as U100 in the treatment of
type 1 diabetes mellitus.
Type 2 diabetes mellitus:
On the basis of three head-to-head trials (EDITION I, II and III), U300 appears
to have the same effect on glycosylated haemoglobin as U100 in the treatment
of type 2 diabetes mellitus.
The PBAC did not accept U300 to have superior comparative safety in terms
of reduced risk of hypoglycaemia.
Based on the acceptance of non-inferiority of both comparative clinical
effectiveness and safety, the PBAC agreed with the following equi-effective
doses for type 2 diabetes mellitus:
 EDITION I:
1U of U300 = 0.91U of U100
 EDITION II:
1U of U300 = 0.90U of U100
 EDITION III:
1U of U300 = 0.88U of U100
The PBAC noted the 28 day shelf life of the U300 and that the increase in the
number of units per cartridge may result in increased wastage in a small group
of patients. The PBAC considered a small reduction in the price of the U300
was appropriate to account for the potential wastage.
10
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
LEUPRORELIN
45 mg injection: modified release
[1 x 45 mg syringe] (&) inert
substance diluent [1 x 2 mL
syringe], 1
DRUG TYPE OR
USE
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
Prostate cancer
Authority Required
(STREAMLINED) listing of an
additional strength of
leuprorelin for the treatment
of locally advanced or
metastatic carcinoma of the
prostate.
The PBAC recommended listing an additional strength (45 mg) of
intramuscularly administered leuprorelin for the treatment of locally advanced
(equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the
prostate. The PBAC accepted that there was a clinical place for the additional
strength and considered that it was acceptably similar to the 3- and 4-month
formulations with regard to effectiveness and the adverse events profile. The
PBAC noted that listing the 45 mg intramuscular formulation would result in
savings to the PBS.
Central precocious
puberty (CPP)
Amendment to the PBS
restriction wording of Lucrin®
Depot Paediatric to specify
that the patient must have
had onset of signs or
symptoms of central
precocious puberty prior to
the age of 8 years (girls) or 9
years (boys).
The PBAC recommended that the criterion pertaining to patient age in the
initial treatment restriction for leuprorelin for the treatment of CPP, be
amended as follows: “Patient must be aged 10 years or younger (girls) or
11 years or younger (boys) AND Patient must have had onset of signs or
symptoms of central precocious puberty prior to the age of 8 years (girls) or
9 years (boys)”. The PBAC noted that there may be a very small number of
patients who may not have initiated treatment before 8 years (girls) or 9 years
(boys) despite onset of symptoms before 8 years (girls) or 9 years (boys), and
therefore considered it may be reasonable to extend the PBS age limit for
initiating leuprorelin therapy.
LUCRIN® DEPOT 6 month PDS
AbbVie Pty Ltd
New listing
(Minor Submission)
LEUPRORELIN
30 mg injection: modified release [1
x 30 mg syringe] (&) inert
substance diluent [1 x 2 mL
syringe], 1
LUCRIN® DEPOT
AbbVie Pty Ltd
Change to listing
(Minor Submission)
11
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
NADROPARIN CALCIUM
pre-filled syringe, 1900, 2850,
3800, 5700, 7600, 9500, 11400,
15200, 19,000 IU anti-Xa/mL
DRUG TYPE OR
USE
Prevention of deep
vein thrombosis
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
Unrestricted benefit listing
and restricted benefit listing
for prevention of clotting
during haemodialysis.
Fraxiparine® and Fraxiparine
Forte®
PBAC OUTCOME
The PBAC recommended the listing of nadroparin (as Fraxiparine and
Fraxiparine Forte) as an Unrestricted Benefit and as a Restricted Benefit listing
(as Fraxiparine) for haemodialysis on a cost-minimisation basis against
enoxaparin.
The equi-effective doses are nadroparin calcium 111.9 IU is equal to
enoxaparin sodium 1 mg. The PBAC advised that this equi-effective dose
calculation appropriately excludes doses for haemodialysis, noting that in
Australian clinical practice unfractionated heparin may also be used in this
setting instead of enoxaparin. The TGA approved indication for Fraxiparine
(nadroparin) includes haemodialysis.
Aspen Pharmacare Australia Pty
Ltd
New listing
(Major Submission)
PARITAPREVIR with
RITONAVIR, OMBITASVIR and
DASABUVIR
PARITAPREVIR with
RITONAVIR, OMBITASVIR,
DASABUVIR and RIBAVIRIN
paritaprevir 75 mg + ritonavir 50
mg + ombitasvir 12.5 mg tablet, 56,
with dasabuvir 250 mg tablet, 56
paritaprevir 75 mg + ritonavir 50
mg + ombitasvir 12.5 mg tablet, 56,
with dasabuvir 250 mg tablet, 56
and ribavirin 200 mg tablet, 168
paritaprevir 75 mg + ritonavir 50
mg + ombitasvir 12.5 mg tablet, 56,
with dasabuvir 250 mg tablet, 56,
and ribavirin 600 mg tablet, 56
VIEKIRA PAK®
VIEKIRA PAK-RBV®
AbbVie Pty Ltd
Hepatitis C
Authority Required
(STREAMLINED) listing for
the treatment of patients with
genotype 1 chronic hepatitis
C (CHC).
The PBAC recommended the Authority Required listing of
paritaprevir/ritonavir/ombitasvir plus dasabuvir (Viekira PAK) and
paritaprevir/ritonavir/ombitasvir plus dasabuvir with ribavirin (Viekira
PAK-RBV) for the treatment of patients with Genotype 1 chronic hepatitis C
(CHC) infection on the basis of non-inferior efficacy and safety with
Ledipasvir/Sofosbuvir (LDV/SOF), recommended in March 2015.
The PBAC considered that it was reasonable to assume that one treatment
course of Viekira PAK/Viekira PAK-RBV was as effective as one course of
LDV/SOF.
The PBAC reiterated that new treatments for CHC infection were very effective
and listing of these products would offer options for treatment of Genotype 1
CHC.
The PBAC reiterated that it was appropriate for the new all oral treatment to be
listed in the General Schedule, rather than Section 100 Highly Specialised
Drug Program, to facilitate the longer term objectives for access to treatment,
increase treatment rates and better outcomes with a view to treat all patients
with CHC over time.
The PBAC did not accept that the treatments are cost-effective at the price
proposed by the sponsor in the overall patient population with Genotype 1
CHC.
12
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
DRUG TYPE OR
USE
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
New listing
The PBAC noted that there was a prevalent population of approximately
230,000 patients with CHC in Australia, of which approximately 50% have
Genotype 1 CHC. The estimates of the number of patients treated with the
availability of an all oral interferon free treatment, presented by the DUSC for
the March 2015 PBAC meeting, indicated that approximately 62,000 patients
with any Genotype CHC could be treated in the next years. The PBAC noted
that at the price and patient estimates submitted by the sponsor, the proposed
budget impact was less than $2 billion over 5 years for the patient population
with Genotype 1 CHC.
(Major submission)
The PBAC confirmed their previous advice to the Minister:
• that there is the high clinical need for all oral interferon-free treatments of
CHC to be made available on the PBS,
• that there was no basis on which to recommend that any one treatment be
more expensive than another,
• there is a large opportunity cost to health care system. Given this large
opportunity cost, the cost of a course of treatment should be set irrespective
of the duration, and that other pricing policies be considered.
PERTUSSIS VACCINEACELLULAR, combined with
DIPTHERIA and TETANUS
TOXOIDS
0.5 ml vial, 1
TRIPACEL®
Prevention of
diphtheria, tetanus
and pertussis
National Immunisation
Program (NIP) listing of an
additional booster dose of
DTaP vaccine for children
aged 18 months.
The PBAC recommended including the 18-month booster of the pertussis
vaccine-acellular, combined with diphtheria and tetanus toxoids (Tripacel), on
the NIP for the prevention of pertussis on the basis of cost-minimisation to the
18-month booster of the combined diphtheria, tetanus and acellular pertussis
(Infanrix) vaccine recommended at the November 2014 PBAC meeting for
inclusion on the NIP. Based on the evidence provided, the PBAC considered it
would be reasonable to conclude that the two vaccines at the 18-month time
point conferred similar efficacy and safety.
Sanofi-aventis Australia Pty Ltd
New listing
(Major submission)
13
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
PNEUMOCOCCAL CONJUGATE
VACCINE (13-valent)
0.5 mL injection
PREVENAR 13®
Pfizer Australia Pty Ltd
DRUG TYPE OR
USE
Prevention of
pneumococcal
disease
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
Re-submission to extend the
listing on the National
Immunisation Program (NIP)
to include the prevention of
pneumococcal disease in
non-Indigenous adults aged
65 years and Indigenous
adults aged 50 years.
PBAC OUTCOME
The PBAC recommended including the 13-valent pneumococcal conjugate
vaccine (13vPCV) on the NIP for the prevention of pneumococcal pneumonia
and invasive pneumococcal disease in adults on the basis of cost-minimisation
to the 23-valent pneumococcal polysaccharide vaccine (23vPPV). The PBAC
recommended that a single dose of 13vPCV be made available to
pneumococcal vaccine naïve non-Indigenous adults aged 65 years and over
and to pneumococcal vaccine naïve Indigenous adults aged 50 years and
over.
Change to listing
(Minor Submission)
The PBAC noted that if 13vPCV were included on the NIP for adults, then
individuals in specified at-risk groups would continue to receive a booster dose
of 23vPPV five years following the primary dose of 13vPCV.
14
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
PONATINIB
15 mg tablet, 60
45 mg tablet, 30
ICLUSIG®
Specialised Therapeutics Australia
Pty Ltd
New listing
(Major submission)
DRUG TYPE OR
USE
Chronic myeloid
leukaemia (CML)
and acute
lymphoblastic
leukaemia (ALL)
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
Re-submission for Authority
Required listing for the
treatment of CML or ALL in a
patient who meets certain
criteria.
PBAC OUTCOME
The PBAC recommended the PBS-listing of ponatinib as an Authority
Required benefit for treatment of CML in (i) Patients who have failed first line
therapy with imatinib or dasatinib or nilotinib and whose CML has the T315I
mutation; (ii) Patients with CML where both nilotinib and dasatinib have failed
or where one of nilotinib or dasatinib has failed and who are intolerant of the
other drug; and for the treatment of relapsed or refractory Philadelphia
chromosome positive (Ph+ ) ALL in patients whose ALL has the T315I
mutation.
The PBAC reaffirmed its previous conclusion that ponatinib is the most active
tyrosine kinase inhibitor for CML patients who carry the T315I mutation, and
that response rates to ponatinib in CML patients with the T315I mutant CML
are similar to those seen in CML patients without this mutation treated with
dasatinib or nilotinib in second line.
The PBAC reaffirmed its view that ponatinib has an inferior toxicity profile to
imatinib, dasatinib and nilotinib, especially with regard to serious vascular
occlusive events.
The PBAC considered that there was a clinical need for treatments of Ph+ ALL
patients without the T315 mutation (including patients with less common
mutations such as F317L and E225V). However, in the absence of additional
evidence, the PBAC could not recommend approval for ponatinib in Ph+ ALL
without the T315 mutation. The PBAC did not alter its view from
November 2014 in recommending the use of ponatinib in clinical scenarios
where its risk:benefit ratios were most favourable. The PBAC would welcome
additional quality evidence of the benefit of pontantib in Ph+ ALL patients
without the T315 mutation to facilitate any future reconsideration.
The PBAC considered that the cost-effectiveness of ponatinib would be
acceptable when benchmarked against the costs of dasatinib and nilotinib,
with adjustments required to account for the toxicity of the treatments. The
equi-effective doses were considered to be ponatinib 30.2 mg daily, dasatinib
102 mg daily and nilotinib 797 mg daily.
15
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
QUADRIVALENT INFLUENZA
VACCINE
0.5 ml pre-filled syringe, 5;
0.5 ml pre-filled syringe, 10;
0.25 ml pre-filled syringe, 5;
0.25 ml pre-filled syringe, 10
DRUG TYPE OR
USE
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
Prevention of
seasonal influenza
National Immunisation
Program (NIP) listing for the
prevention of seasonal
influenza in the currently
eligible patient populations.
The PBAC recommended the listing of the quadrivalent influenza vaccine,
FluQuadri, on the NIP – Designated Vaccines List for the prevention of
seasonal influenza. The recommendation was based on a cost-minimisation
with Fluarix Tetra quadrivalent influenza (for individuals 3 years and above)
and with trivalent influenza vaccine (for individuals less than 3 years).
Severe active
granulomatosis with
polyangiitis and
microscopic
polyangiitis
The March 2015 major
submission sought Section
100 (Highly Specialised
Drugs Program) Authority
Required listing for rituximab
for remission induction in
patients with severe active
granulomatosis with
polyangiitis (GPA) and
microscopic polyangiitis
(MPA).
The PBAC recommended the listing of rituximab, on the basis that it should be
available only under special arrangements under the Section 100 Highly
Specialised Drugs Program, for remission induction in patients with severe
active GPA and MPA.
FLUQUADRI®
Sanofi-aventis
New listing
(Major Submission)
RITUXIMAB
injection for infusion
500mg/50mL
Mabthera®
Roche Products Pty Ltd.
(Deferral from March 2015 PBAC
meeting)
At its March 2015 meeting, the PBAC considered that there is a high clinical
need for rituximab for rare and potentially life-threatening conditions such as
GPA and MPA. The PBAC considered that the claim of non-inferior
comparative effectiveness and safety of rituximab compared to
cyclophosphamide made in the submission was reasonable.
The PBAC requested the Department negotiate a Risk Share Arrangement in
a manner that can be implemented and managed by the Department.
16
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
RIVASTIGMINE
13.3 mg/24 hours patch, 30
DRUG TYPE OR
USE
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
Dementia
Authority Required listing of
an additional strength for the
treatment of mild to
moderately severe
Alzheimer-type dementia.
The PBAC recommended the listing of rivastigmine for the treatment of mild to
moderately severe Alzheimer disease, under the same conditions as current
PBS-listed strengths.
Type 2 diabetes
mellitus
Authority Required
(STREAMLINED) listing for
triple oral therapy with
metformin and a sulfonylurea
in patients with type 2
diabetes mellitus.
The PBAC recommended the listing of saxagliptin for the treatment of type 2
diabetes mellitus in combination with metformin and sulfonylurea (triple oral
therapy). The recommendation was formed on the basis of a cost minimisation
analysis compared with dapagliflozin. The equi-effective doses are saxagliptin
5mg and dapagliflozin 10mg.
EXELON®
Novartis Pharmaceuticals Australia
Pty Limited
Change to listing
(Minor Submission)
SAXAGLIPTIN
2.5 mg tablet, 28
5.0 mg tablet, 28
ONGLYZA®
AstraZeneca Pty Ltd
Change to listing
(Major Submission)
17
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
SAXAGLIPTIN and METFORMIN
XR
saxagliptin 5 mg + metformin
hydrochloride 500 mg tablet:
modified release, 28
saxagliptin 5 mg + metformin
hydrochloride 1000 mg tablet:
modified release, 28
saxaglitpin 2.5 mg + metformin
hydrochloride 1000 mg tablet:
modified release, 56
DRUG TYPE OR
USE
Type 2 diabetes
mellitus
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
Authority Required
(STREAMLINED) listing for
triple oral therapy with
metformin and a sulfonylurea
in patients with type 2
diabetes mellitus.
PBAC OUTCOME
The PBAC recommended that the listing of saxagliptin+metformin XR for the
treatment of type 2 diabetes mellitus be extended to include use in
combination with a sulfonylurea (triple oral therapy).
KOMBIGLYZE® XR
AstraZeneca Pty Ltd
Change to listing
(Minor Submission)
18
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
SITAGLIPTIN
SITAGLIPTIN and METFORMIN
SITAGLIPTIN and METFORMIN
XR
sitagliptin 100 mg tablet, 28
sitagliptin 50 mg tablet, 28
sitagliptin 25 mg tablet, 28
sitagliptin 50 mg + metformin
hydrochloride 1000 mg tablet, 56
sitagliptin 50 mg + metformin
hydrochloride 850 mg tablet, 56
sitagliptin 50 mg + metformin
hydrochloride 500 mg tablet, 56
sitagliptin 100 mg + metformin
hydrochloride 1000 mg tablet:
modified release, 28 sitagliptin 50
mg + metformin hydrochloride 1000
mg tablet: modified release, 56
DRUG TYPE OR
USE
Type 2 diabetes
mellitus (T2DM) –
triple oral therapy
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
Authority Required
(STREAMLINED) listing for
triple oral therapy with
metformin and a sulfonylurea
in patients with T2DM.
The PBAC recommended the listing of sitagliptin and the sitagliptin+metformin
fixed dose combinations (FDCs) for the treatment of T2DM in combination with
metformin and a sulfonylurea (triple oral therapy). The recommendation was
formed on the basis of a cost minimisation analysis compared with
dapagliflozin in combination with metformin and a sulfonylurea. The
equi-effective doses are sitagliptin 100mg and dapagliflozin 10mg.
JANUVIA®
JANUMET®
JANUMET XR®
Merck Sharp & Dohme (Australia)
Pty Limited
Change to listing
(Major Submission)
19
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
STRONTIUM RANELATE
2 g granules for oral suspension,
28 x 2g sachets
DRUG TYPE OR
USE
Osteoporosis
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
To not delist the current
Authority Required listing for
the treatment of severe
established osteoporosis.
PBAC OUTCOME
The PBAC recommended that strontium ranelate should remain listed on the
PBS for the treatment of severe established osteoporosis in patients unable to
use other osteoporosis medications and without cardiovascular
contraindications.
PROTOS®
Servier Laboratories
Change to listing
(Major Submission)
The PBAC recalled that in April 2014, the TGA issued an alert warning against
use of the drug in patients with cardiovascular contraindications and restricting
use to patients unable to take other osteoporosis medications. As a result, the
PBAC recommended changes to the strontium ranelate restriction in July 2014
and noted that it was of a mind to recommend delisting of strontium from the
PBS. However, the PBAC considered that it would be appropriate for the
sponsor to have the opportunity to establish the cost effectiveness of strontium
ranelate in patients with severe established osteoporosis unable to use other
treatments due to contraindication or intolerance.
On the basis of meta-analysis presented in the submission, for every 100
patients treated with strontium ranelate in comparison to placebo:
 Approximately 9 fewer patients would have a new morphometric vertebral
fracture (i.e. detectable on x ray or other imaging but not necessarily
clinically apparent) over 3 years
 Approximately 3 fewer patients would have a new clinical vertebral fracture
over 3 years
 Approximately 2 fewer patients would have a new clinical non-vertebral
fracture over 3 years
 There would be no difference in the number of patients with a new hip
fracture over 3 years
 Approximately 5 additional patients would experience a treatment-related
adverse event over 3 years
The PBAC considered that the claim of superior comparative effectiveness
compared with placebo may be reasonable and that the claim of inferior
comparative safety compared with placebo was reasonable.
A revised base case provided in the pre-PBAC response resulted in an ICER
of around $45,000 to $75,000 per QALY. The PBAC considered that if the
submission was seeking PBS-listing of strontium ranelate, it would not have
considered this ICER to be sufficiently cost-effective for this indication.
Accordingly, as the submission is seeking continued listing of strontium
20
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
DRUG TYPE OR
USE
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
ranelate, the PBAC considered that a pragmatic approach would be to
recommend continued listing of strontium on the condition that the price of
strontium is reduced such that the ICER would be around $15,000 to $45,000
per QALY.
SUCROFERRIC OXYHYDROXIDE
Iron (as sucroferric oxyhydroxice)
500 mg tablet: chewable, 90
VELPHORO®
Fresenius Medical Care Pty Ltd
Change to listing
Hyperphosphataemia
To request that the clinical
criterion “not to be used in
combination with any other
phosphate binder” be
amended to ensure
concomitant use with calcium
could occur. Any change
would also apply to
sevelamer and lanthanum.
The PBAC considered that current utilisation of strontium ranelate is relatively
small compared with the overall osteoporosis drug market and will continue to
decline over time.
The PBAC noted the concerns regarding the exclusion of patients taking
calcium, aluminium or magnesium based agents concomitantly with sucroferric
oxyhydroxide, sevelamer or lanthanum. The PBAC recommended that the
clinical criterion for sucroferric oxyhydroxide, sevelamer and lanthanum be
amended from “The treatment must not be used in combination with any other
phosphate binding agents” to “The treatment must not be used in combination
with any other non-calcium phosphate binding agents”.
(Other)
21
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
TESTOSTERONE
testosterone 1% (50 mg/5 g) gel,
30 x 5 g sachets
DRUG TYPE OR
USE
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
Androgen deficiency
Amendment to the revised
PBS restrictions to enable
access by transgender and
intersex patients.
The PBAC recommended amending the restriction wording for testosterone to
remove the population criterion ‘patient must be male’. The PBAC considered
that the remaining requested changes to the restrictions for testosterone
products were complex in nature. The PBAC recommended a stakeholder
meeting be held between the Department, representatives of the National
LGBTI Health Alliance and other consumer representatives, relevant clinicians,
the Department of Human Services, the sponsors of testosterone preparations
and PBAC members. The aim of this meeting would be to determine an
appropriate restriction arrangement (including appropriate prescriber groups)
for transgender and intersex populations. A revised restriction would need to
reflect the need for these patients to maintain continuity of care with a primary
care provider.
Chronic obstructive
pulmonary disease
Authority Required
(STREAMLINED) listing for
the treatment of patients with
chronic obstructive
pulmonary disease.
The PBAC recommended the listing of tiotropium/olodaterol FDC as an
Authority required (STREAMLINED) benefit for the treatment of chronic
obstructive pulmonary disease for patients already stabilised on concomitant
long acting muscarinic receptor antagonist (LAMA) and long-acting selective
β2 agonist (LABA) therapy.
testosterone 2% (30 mg/1.5 mL
actuation) transdermal solution, 60
actuations
testosterone 2.5 mg/24 hours
patch, 60
testosterone 5 mg/24 hours patch,
30
Various sponsors
National Lesbian, Gay, Bisexual,
Transgender, and Intersex (LGBTi)
Health Alliance
Change to listing
(Minor submission)
TIOTROPIUM BROMIDE with
OLODATEROL
HYDROCHLORIDE
tiotropium 2.5 microgram/actuation
+ olodaterol 2.5
microgram/actuation inhalation:
solution for, 60 actuations
SPIOLTO® RESPIMAT®
Boehringer Ingelheim Pty Limited
The PBAC recommended the listing on a cost-minimisation basis to the
existing LAMA/LABA fixed dose combinations, umeclidinium/vilanterol and
glycopyrronium/indacaterol. The equi-effective doses are considered to be
tiotropium 5 microgram with olodaterol 5 microgram (two inhalations daily),
umeclidinium 62.5 microgram with vilanterol 25 microgram (daily), and
glycopyrronium 50 microgram with indacaterol 110 microgram (daily).
New listing
(Major Submission)
22
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
TRASTUZUMAB
solution for subcutaneous injection,
600 mg/5 mL, 1
HERCEPTIN®
Roche Products Pty Ltd
New listing
(Minor Submission)
DRUG TYPE OR
USE
Breast cancer
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
Authority Required listing of a
subcutaneously administered
formulation for the treatment
of HER2 positive breast
cancer.
The PBAC recommended the General Schedule and Schedule 100 Efficient
Funding of Chemotherapy (‘Related Pharmaceutical Benefits’) listing of
trastuzumab subcutaneous (SC), for patients with locally advanced human
epidermal growth factor receptor 2 (HER2) positive breast cancer, early HER2
positive breast cancer and metastatic (Stage IV) HER2-positive breast cancer.
The PBAC was satisfied that trastuzumab SC is safe and effective in
treatment-naïve patients initiating on this form of trastuzumab; that there is no
evidence of significant differences in clinical effectiveness or safety compared
with the intravenous (IV) form, and there is no evidence that identifies
populations in whom the risks of using the SC form of trastuzumab are
disproportionately high. The PBAC was concerned that only very limited
clinical efficacy and safety data was provided in support of switching between
trastuzumab SC and its IV form, as this is likely to occur in clinical practice. In
addition, the chemotherapy partners in practice will be broader than those for
which evidence was provided, and trial evidence was not available for the
metastatic breast cancer setting.
The PBAC concluded that it could not be completely assured of the efficacy
and safety of trastuzumab SC in clinical practice. However the PBAC
considered that, on balance it was appropriate to recommend trastuzumab SC
be listed on the PBS and that patients with breast cancer should be able to
access trastuzumab SC via the PBS in the same way as the currently listed
trastuzumab IV and without any restriction on switching between the different
forms. The recommendation was made on the basis that the listing should, at
worst, be cost-neutral for government.
23
JULY 2015 PBAC MEETING – POSITIVE RECOMMENDATIONS
DRUG, SPONSOR, TYPE OF
SUBMISSION
TRASTUZUMAB
powder for I.V. infusion, 60 mg
vial,1
powder for I.V. infusion, 150 mg
vial, 1
DRUG TYPE OR
USE
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
Gastric cancer
Section 100 (Efficient
Funding of Chemotherapy)
Authority Required listing for
the treatment of patients with
HER2 positive, metastatic
(equivalent to stage IV)
adenocarcinoma of the
stomach or
gastro-oesophageal junction.
The PBAC recommended extending the listing of trastuzumab under
Section 100 (Efficient Funding of Chemotherapy) for the treatment of HER2
positive, metastatic (equivalent to stage IV) adenocarcinoma of the stomach or
gastro-oesophageal junction. This recommendation reflected a wide range of
high to very high incremental cost-effectiveness ratios that were acceptable in
the context of a modest but potentially meaningful extension of overall survival
in a difficult to treat cancer affecting a small number of patients, and with
effective controls to limit the financial costs to the PBS.
Medicinal food
Amendment to the current
PBS restriction 'NOTE' to
allow an increase in the
maximum quantity.
The PBAC noted advice from the Nutritional Products Working Party and
recommended to amend the current administrative advice note, allowing an
increased supply of Peptamen® Junior from the listed maximum quantity of
8 cans up to a maximum of 20 cans to allow a one month supply for an infant
or child at an appropriate dose to meet the total nutritional requirements for
their respective age range.
HERCEPTIN®
Roche Products Pty Ltd
Change to recommended listing
(Major Submission)
TRIGLYCERIDES MEDIUM
CHAIN FORMULA
oral liquid: powder for, 400 g
PEPTAMEN JUNIOR®
Nestle Health Science (Nestle
Australia Ltd)
Change to listing
(Minor Submission)
24